Method Validation

Implementation of the recently adopted guideline ICH Q2(R2) on Analytical Procedure Validation can present challenges. In this webinar, Dr. Margareth Marques from the USP will discuss practical guidance around accuracy, precision, limit of quantitation and limit of detection. Then Neil Lander from Waters Corporation will walk us through an Empower CDS tool that enhances the efficiency, accuracy, and compliance of the method validation process. A panel discussion will follow. 

Key Learning Objectives

• Address challenges in the implementation of Q2(R2)
• Discover the benefits of the Empower Method Validation Manager

Who should attend

Pharmaceutical testing laboratory scientists and managers, pharmaceutical quality control staff, scientific review staff of regulatory bodies for pharmaceutical products involved with LC procedures and anyone involved in method validation.

Presenter: Margareth R. C. Marques, Ph.D. (Sr. Principal Scientist, United States Pharmacopeia)

Margareth Marques, Ph.D., is a Sr. principal scientist at the Science Department at the United States Pharmacopeia, Scientific liaison to the USP Expert Committee on Dosage Forms working on general chapters for performance tests (dissolution/drug release), and for some pharmaceutical dosage forms (products applied to the skin, ophthalmic products, etc.), also responsible for the USP general chapters on osmolality, method validation and method transfer. Dr. Marques is also responsible for developing specifications for reagents, test solutions, buffer solutions, etc., used in USP – NF monographs. She manages the USP database on chromatographic columns, the USP database on dissolution methods and the USP web site on column equivalency. She has a B.Sc. and an M. Sc. both in Pharmacy by the University of Sao Paulo, Brazil. She has a Ph. D. in Analytical Chemistry by the State University of Campinas, Brazil. She managed analytical laboratories at Ciba-Geigy, Sandoz, and Astra.

Presenter: Neil Lander (Principal Product Manager - Informatics Group, Waters Corporation)

Neil has worked for Waters Corporation since 1994 and has held a variety of positions including Technical Support Specialist, Technical Trainer, Manager Customer Education and currently, Principal Marketing Manager in Waters in the Informatics group. Neil provides internal support for Empower CDS software and is focused on developing laboratory software solutions that help organizations achieve their scientific and operational objectives. Prior to joining Waters Corporation, he was an analytical chemist where he gained experience in both the cosmetics and specialty chemical industries.

Presenter: Moderated by: Isabelle Vu Trieu (Pharmaceutical Market Development Manager, Americas, Waters Corporation)

Isabelle is a business development professional dedicated to delivering benefits to analytical scientists in the life sciences industry. With over 20 years of experience in providing chromatography and mass spectrometry solutions, Isabelle is particularly interested in helping pharmaceutical scientists achieve the data quality and integrity needed to drive decisions for drug quality, safety and efficacy. Isabelle joined Waters in 2009 and currently manages the development of the pharmaceutical market in the Americas. She holds Masters’ degrees in Chemistry from Columbia University and the University Claude Bernard in Lyon, France as well as a Chemical Engineering degree from Ecole Supérieure de Chimie Physique Electronique in Lyon, France.